Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04565405
Status:
UNKNOWN
Last Update Posted:
2020-09-25
First Post:
2020-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003902', 'term': 'Detergents'}], 'ancestors': [{'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Eligible patients will be randomized in 1:1 fashion using permuted blocks with different block sizes. The subjects and lab operators will be blinded to the block size and randomization. In the event unmasking need to be performed, a staff who is not involved in this study from Clinical Trial Unit will perform the unmasking.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a single centre, single blinded, randomized cross over study comparing two decontamination procedures Detergent (A) and Sterile water (B) on inner cannulas.\n\nTo avoid the influence of confounding covariates, we propose to have a cross over study. The cross over patient will act as his own control. The selected patients will be randomly allocated to sequence AB or BA in 1:1 fashion using permuted blocks with different block sizes.\n\nThe change of sequence A \\> B and B \\> A will take place only after minimum of 24 hours after the first part of sequence has been completed.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-11-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of water vs detergent in cleaning tracheostomy inner cannulas', 'timeFrame': '1 week', 'description': 'Compare the colony forming units / ml before and after cleaning with water vs detergent'}], 'secondaryOutcomes': [{'measure': 'Economic evaluation', 'timeFrame': '2 years', 'description': 'Compare the expenses incurred from cleaning the inner cannulas using water vs detergent'}, {'measure': 'Microbiological evaluation', 'timeFrame': '2 weeks', 'description': 'Compare the profile of bacteria identified from a proportion of samples sent for bacterial culture between the water and detergent groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tracheostomy', 'Inner cannulas', 'Decontamination', 'Microbiological evaluation'], 'conditions': ['Tracheostomy Complication']}, 'referencesModule': {'references': [{'pmid': '17980239', 'type': 'BACKGROUND', 'citation': 'Bjorling G, Belin AL, Hellstrom C, Schedin U, Ransjo U, Alenius M, Johansson UB. Tracheostomy inner cannula care: a randomized crossover study of two decontamination procedures. Am J Infect Control. 2007 Nov;35(9):600-5. doi: 10.1016/j.ajic.2006.11.006.'}]}, 'descriptionModule': {'briefSummary': 'Biofilms pose a potential risk with reusable inner cannulas, by increasing the risk of infection. Effective decontamination is vital in eliminating these biofilms. An appropriate method of cleaning and decontamination to make inner cannula safe for reuse should be practiced. The current recommendations for cleaning inner cannula are varied with multiple techniques being put forth. The current practice of using sterile water to clean inner cannula is not supported by strong evidence. This Randomized Controlled Study looks into the microbiological efficacy of sterile water in cleaning inner cannulas.', 'detailedDescription': 'Tracheostomy Care of Patients:\n\nThe tracheostomy care of all patients included in the study will be the same as any other tracheostomy patient in the hospital, as directed by the tracheostomy care nursing policy. Before study procedure, inner cannula is to be checked to ensure it is not clogged with secretion, any secretion is to be removed with suction.\n\nDecontamination methods:\n\nPatients may fall under group A or group B as determined by the random allocation.\n\nPatients in decontamination group A: Detergent\n\nPre Decontamination:\n\n* The inner cannula care will be removed using aseptic precautions.\n* 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.\n* The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.\n* Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.\n\nDecontamination:\n\n* Inner cannula will be cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK).\n* The cleaning is done as per manufacturers recommendation.\n\nPost Decontamination:\n\n* Using aseptic technique, 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.\n* The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.\n\nPatients in decontamination group B: Water\n\nPre Decontamination:\n\n* The inner cannula care will be removed using aseptic precautions.\n* 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.\n* The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.\n* Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.\n\nDecontamination:\n\n• Inner cannula is cleaned as per the current tracheostomy care guidelines as directed by the Nursing Policy for Tracheostomy Care, Changi General Hospital. Only Sterile water is recommended as per the policy.\n\nPost Decontamination:\n\n* Using aseptic technique, 10 ml of normal saline will be flushed along the inner surface in an uniform manner over 30 seconds. The inner cannula will be turned gently to ensure that the entire inner surface has been flushed by Normal Saline.\n* The solution will be collected in the sterile bottle and sent for laboratory analysis of colony counts.\n\nCrossover of Patients:\n\nTo avoid the influence of confounding covariates, we propose to have a cross over study. The cross over patient will act as his own control. The selected patients will be randomly allocated to sequence AB or BA in 1:1 fashion using permuted blocks with different block sizes. The subjects and lab operators will be blinded to the block size and randomization.\n\nThe change of sequence A \\> B and B \\> A will take place only after minimum of 24 hours after the first part of sequence has been completed. Exclusion criteria will still be applicable after completion of one part of the sequence. Small proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.\n\nLab Method for Colony Counts:\n\nFrom the flush solution, 100 microlitres and further sequential serial dilutions of 1:10 (in saline) are cultured directly onto blood agar plates. After 72 hours aerobic incubation at 35oC, all plates are examined and growth from plates with 10 to 100 colonies per plate are counted. Total bacterial growth will be expressed as colony-forming unit (cfu)/ml.\n\nSmall proportion of pre decontamination samples will be randomly selected for typing and naming of organisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients under the purview of the tracheostomy care team at Changi General Hospital will be considered for inclusion in the study.\n* Patients aged between 21 - 100 years\n* Patients with a tracheostomy tube in situ\n\nExclusion Criteria:\n\n* Pregnant women\n* Prisoners\n* Patients with documented HIV, Hep C, Hep B\n* Patients with active tuberculosis\n* Patients being treated in Intensive Care Units\n* Patients with ongoing antibiotic treatment or within the last 24 hours\n* Unstable patients needing cardiorespiratory support'}, 'identificationModule': {'nctId': 'NCT04565405', 'briefTitle': 'Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Inner Cannula'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AB (Detergent (A) followed by sterile water (B))', 'description': 'Sequence: Detergent (A) followed by sterile water (B)\n\nThe inner cannula will be cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK) in the first visit, and then cleaned with sterile water in the second visit, at a minimum period of 24 hrs apart. Laboratory analysis of colony counts will be conducted on the saline flushing pre- and post-decontamination for each washing.', 'interventionNames': ['Other: Detergent', 'Other: Sterile water']}, {'type': 'EXPERIMENTAL', 'label': 'BA (Sterile water (B) followed by detergent (A))', 'description': 'Sequence: Sterile water (B) followed by detergent (A)\n\nThe inner cannula will be cleaned with sterile water in the first visit, and then cleaned with commercially available tracheostomy cleaning fluid / powder (Ex: Trachoe - Kapitex healthcare, UK) in the second visit, at a minimum period of 24 hrs apart. Laboratory analysis of colony counts will be conducted on the saline flushing pre- and post-decontamination for each washing.', 'interventionNames': ['Other: Detergent', 'Other: Sterile water']}], 'interventions': [{'name': 'Detergent', 'type': 'OTHER', 'description': 'The tracheostomy inner cannulas will be washed with detergent.', 'armGroupLabels': ['AB (Detergent (A) followed by sterile water (B))', 'BA (Sterile water (B) followed by detergent (A))']}, {'name': 'Sterile water', 'type': 'OTHER', 'description': 'The tracheostomy inner cannulas will be washed with sterile water.', 'armGroupLabels': ['AB (Detergent (A) followed by sterile water (B))', 'BA (Sterile water (B) followed by detergent (A))']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Lay Hwa Yew', 'role': 'CONTACT', 'email': 'yew.lay.hwa@singhealth.com.sg', 'phone': '65-68502375'}, {'name': 'Rajkumar Chandran', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Lu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alvin Tan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Si Huei Tan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Siew Yong Ng', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Soon Keow Neo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jia Yan Lim', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qiu Sha Meng', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fazlina Bte Abdul Hathi', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Liping Zhao', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Trials & Research Unit', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Seok Hwee Koo, PhD', 'role': 'CONTACT', 'email': 'seok_hwee_koo@cgh.com.sg', 'phone': '68504929'}], 'overallOfficials': [{'name': 'Hong Eng Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Nurse Clinician', 'investigatorFullName': 'Chan Hong Eng', 'investigatorAffiliation': 'Changi General Hospital'}}}}